Yap 1979.
Methods | Randomised, parallel group study conducted in USA. Patient, carer, assessor blind. No clear explanation of withdrawals. Pharaceutical and government funding. No recruitment dates given. | |
Participants | Adults with mixed cancer. 56 patients, 60 episodes enrolled. 52 episodes, 48 patients completed. | |
Interventions | 2 groups. 10 mg versus 50 mg troche clotrimazole, for 14 days. | |
Outcomes | Clinical and mycological eradication (culture). Unclear when assessment made. | |
Notes | As number of episodes 60 nearly same as number of patients so episodes used in analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Quote: "A randomised double blind trial....". Quote: "....a randomised double blind technique was used to divide the patients into two groups....". |
Allocation concealment? | Unclear risk | No information given. |
Blinding of participants and carers? | Low risk | Quote: "A randomised double blind trial....". |
Blinding of outcome assessors? | Low risk | Quote: "A randomised double blind trial....". |
Incomplete outcome data addressed? | Unclear risk | Quote: "56 cancer patients with 60 episodes of oropharyngeal candidiasis were entered into he study between September 1976 and September 1977". Quote: "Eight patients 8 episodes were considered inevaluable". Of the remaining 48 patients there were 52 episodes of infection. Comment: We don't know which group these patients were in. |
Free of selective reporting? | Low risk | Comment: Clinical and mycological eradication (culture). |
Free of other biases? | High risk | Quote: "If there was no clinical improvement after 5 days or the patients condition necessitated the start of systemic antifungal therapy, administration of the troches was discontinued". Possible bias due to episodes rather than patients and data not independent. Comment: Pharmaceutical and government funding. |